FDA waves Loxo through for sec­ond 'break­through' in tis­sue-ag­nos­tic can­cer ther­a­py

Three months ago at AS­CO, Loxo On­col­o­gy wowed the crowd at the big can­cer con­fer­ence with some ear­ly-stage da­ta for its sec­ond ge­net­i­cal­ly tar­get­ed can­cer drug can­di­date. To­day, the biotech an­nounced that the FDA seems sim­i­lar­ly im­pressed, of­fer­ing a break­through drug des­ig­na­tion to short­en the reg­u­la­to­ry time­line just as Loxo has hoped.

In the in­ter­im Phase I/II snap­shot pro­vid­ed at AS­CO, LOXO-292 spurred a 77% over­all re­sponse rate for RET fu­sion-pos­i­tive cas­es, the ma­jor­i­ty of which be­longed to the non-small cell lung can­cer. In RET-mu­tant medullary thy­roid can­cer the rate dropped to 45%.

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